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Latest From Elizabeth Orr
On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.
Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.
Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.
An $800m lawsuit filed by the state of California against Johnson & Johnson for alleged fraudulent marketing of pelvic mesh products is in the hands of a state judge after the conclusion of a 10-week trial. This is the first lawsuit brought by a state against a pelvic mesh manufacturer to go to trial.
Legal service ads that attempt to recruit patient plaintiffs for product-safety lawsuits against drug and device companies by resembling official medical alerts or recall notices may be deceptive or unfair, the US Federal Trade Commission warned in a recent set of letters.
Former US FDA cardiac device medical officer John Laschinger spoke to Medtech Insight about his work at the agency and his move to device-maker W.L. Gore & Associates as cardiac chief medical advisor.